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NCT02647086 · ClinicalTrials.gov registry record · Phase 1
Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)
A Phase 1 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02647086: Completed Phase 1 study, sponsored by Regeneron Pharmaceuticals.
NCT02647086 is a Phase 1 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02647086, a Phase 1 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with moderate to severe AD. The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7), study period 2 (day 8 to 50), and a follow-up period (day 51 to 135 \[end of study\]). Following completion of study period 2 (Day 50), patients will be given the option to enroll into the Open-Label Extension (OLE) study R668-AD-1225. Patients who decline will be followed for the next 12 weeks (Day 135).
Interventions
- DRUG Dupilumab
- DRUG Midazolam
- DRUG Omeprazole
- DRUG Caffeine
- DRUG Warfarin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT02647086 record still lists
NCT02647086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 5 interventions - of which Dupilumab is the first listed.
NCT02647086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02647086 about?
NCT02647086 is a clinical study titled "Open Label, Drug-Drug Interaction (DDI) Study of Dupilumab (REGN668/SAR231893) in Patients With Moderate to Severe Atopic Dermatitis (AD)". This is an open-label, single-sequence DDI study designed to examine the effects of dupilumab on the pharmacokinetics of selected cytochrome P450 substrates in adult patients with moderate to severe AD. The study consists of a screening period (day -35 to -2), study period 1 (day -1 to 7), study pe...
What is the current status of trial NCT02647086?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2015-12. Estimated completion is 2016-07.
What interventions are being tested in trial NCT02647086?
The interventions under investigation include: Dupilumab (DRUG), Midazolam (DRUG), Omeprazole (DRUG), Caffeine (DRUG), Warfarin (DRUG).
Who is sponsoring clinical trial NCT02647086?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02647086's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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